FDA Completes Guidance on Developing Biosimilars

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By Alex Ruoff

Drugmakers received guidance from the FDA Dec. 28 on developing cheaper imitations of certain biologic drugs, known as biosimilars.

The guidance will help drugmakers develop a clinical pharmacology program to support a decision that a proposed biosimilar isn’t meaningfully different clinically from a branded or reference product, the Food and Drug Administration said. The document is meant to assist drugmakers with proving they have created a new drug that can be used in the same way as an existing one.

Drug industry stakeholders have been paying close attention to FDA guidance on biosimilars to ensure they can get agency approval for new alternatives to existing biologics, Michael Reilly, executive director of the Alliance for Safe Biologic Medicines, told Bloomberg BNA Dec. 28. The U.S. biosimilar market remains relatively nascent, with only a handful approved for use over the past two years.

Biosimilars are typically low-cost imitations of existing biologic drugs, which have been used to treat conditions like anemia, rheumatoid arthritis and various forms of cancer. The Affordable Care Act established an abbreviated pathway for the FDA to approve biosimilar drugs in 2010. The agency approved the first biosimilar for marketing in the U.S. in March 2015.

Clarity Concern

Industry groups have criticized the FDA for not being clear on what type or scope of information is needed to differentiate a “similar” molecule from one that is considered “highly similar” or “highly similar with fingerprint-like similarity” ( 08 LSLR, 8/22/14 ).

The guidance outlines four possible outcomes for the analytical comparison of a proposed biosimilar with its reference product, including determinations of not similar, similar, highly similar and highly similar with fingerprint-like similarity.

The FDA has said the guidance discussed some of the overarching concepts related to clinical pharmacology studies for biosimilar products; approaches for developing the appropriate clinical pharmacology database; and the utility of modeling and simulation for designing clinical trials. Clinical pharmacology is the study of how drugs affect humans.

The guidance finalizes draft guidance issued by the agency in May 2014 ( 08 LSLR, 5/16/14 ).

In a Federal Register notice (FDA-2013-N-0879) set for release Dec. 29, the FDA said the final guidance contains some revisions based on public comments but the changes are for clarity and aren’t substantive.

To contact the reporter on this story: Alex Ruoff in Washington at aruoff@bna.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bna.com

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